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De-escalation of Anti-TNF Therapy in Adolescents and Young Adults With IBD With Tight Faecal Calprotectin and Trough Level Monitoring (FREE)
BACKGROUND/RATIONALE: Treatment outcomes of patients with inflammatory bowel disease (IBD) have improved enormously during the past decade due to the use of anti-tumour necrosis factor (anti-TNF) therapy. As a result, 67 to 91% of paediatric patients and 66% of adult patients is still in sustained remission two years after the initiation of anti-TNF therapy. Prolonged use of anti-TNFs comes with disadvantages such as dose dependent susceptibility to infections and dermatological adverse effects. Preliminary, mostly uncontrolled studies suggest that dose reduction by dosing interval lengthening is a realistic option in a relevant proportion of patients with IBD, provided that intensive follow-up is applied. OBJECTIVE: To evaluate whether a faecal calprotectin (FC) guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD, compared with an unchanged dosing interval.
Details
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | Phase 4 |
| Status | ENROLLING_BY_INVITATION |
| Enrolment | 148 |
| Start date | 2021-03-11 |
| Completion | 2026-03 |
Conditions
- Inflammatory Bowel Diseases
- Crohn Disease
- Colitis, Ulcerative
Interventions
- Infliximab
- Adalimumab
Primary outcomes
- cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up — 48 weeks
Out-of-range FC results are defined as fecal calprotectin above the target range (i.e. \>250 μg/g for CD patients; \>150 μg/g for UC patients) and at least 100 μg/g increase compared with the previous result, unless the previous result was already above the target range.
Countries
Belgium, Netherlands, Spain